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Case series study of Tiaogan Anshen Granule in treating chronic insomnia

Case series study of Tiaogan Anshen Granule in treating chronic insomnia

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070159
Enrollment
Unknown
Registered
2023-04-04
Start date
2023-02-27
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic insomnia

Interventions

Sponsors

The First Affiliated Hospital of Guangdong Pharmaceutical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Those who meet the diagnostic criteria for chronic insomnia. 2. It is consistent with the diagnosis of liver depression and qi stagnation in TCM. 3. No gender limit, age = 18 years old. 4. Be able to understand the content of the scale and actively cooperate with the treatment. 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Sleep disorder caused by mental disorder, physical disease, drug or substance abuse, such as respiratory related sleep disorder, restless leg syndrome, periodic limb movement disorder, circadian festival Rhythmic sleep - insomnia caused by wakefulness disorder, persistent pain, malignant tumor, stroke, etc; 2. Those who have taken sleeping pills, antidepressants, anti-anxiety and other psychotropic drugs or received relevant treatment within 7 days; 3. Patients with clinically diagnosed liver and kidney dysfunction, or transaminase AST or ALT greater than 2 times the upper limit of normal, and blood creatinine or blood urea nitrogen greater than the upper limit of normal; 4. Those who have received surgery within 3 months or are expected to undergo surgery within 1 month; 5. There are other serious diseases that lead to poor prognosis or reduced survival rate, such as acute infection, septicemia, malignant tumor, other important organ diseases, and other serious uncontrolled diseases People with unified diseases; 6. Women of childbearing age who are pregnant or lactating and do not take adequate contraceptive measures; 7. People who are allergic to Tiaogan Anshen granules (or related ingredients); 8. Those who have participated in other clinical trials in the past month; 9. Any other medical conditions that the researcher believes may put the patient at risk or affect the research results, or that the researcher believes there are medical conditions that are not suitable for the study, including drugs Or alcohol abuse or mental illness, which affects the patient's ability to follow the protocol or follow-up procedures.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index ;

Secondary

MeasureTime frame
Insomnia severity index;Hamilton Anxiety Scale;Hamilton Depression Scale;TCM Syndrome Scale of Glycolipid Metabolism;

Countries

China

Contacts

Public ContactGuo Jiao; Jin Yinghua

The first hospital affiliated to guangdong pharmaceutical university

gyguoyz@163.com020-39352609

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026